TAVR in 2023: Who Should Not Get It?
Section snippets
Evolution of TAVR: From Prohibitive- to Low-Risk Cohort
The first THV designed by Cribier et al1 was a stainless-steel stent (23 mm in diameter and 17 mm in height) containing a trileaflet valve made of bovine pericardium, compatible with a 24-French (F) introducer sheath, and was implanted using anterograde transseptal approach. Since then, there has been substantial refinement in the design of both THVs and delivery systems, transforming what was a challenging intervention into a standardized, streamlined procedure. The first landmark randomized
Bicuspid Aortic Valve
BAV can be associated with AS (12% to 37%), AR (13% to 30%), or both. Furthermore, involvement of the aorta leads to aortic dilatation in 20% to 40% of cases.12 In 2019, the Food and Drug Administration approved TAVR for patients at low risk regardless of valve morphology, even though patients with BAV were excluded from the randomized cohorts of the pivotal trials.2,3 To date, there remain no randomized data comparing TAVR with surgery in patients with BAV, and the available data are primarily
Unicuspid Aortic Valve
Unicuspid aortic valve (Figure 3) is a rare congenital disease with an estimated incidence of 5%.23 Isolated AS (7%) is an uncommon presentation; most patients (93%) present with mixed AS and AR at the time of diagnosis.24 As with patients with BAV, management of patients with unicuspid aortic valve is challenging because most present at a young age and commonly have associated aortic pathologies. Data from the Mayo Clinic registry suggest successful AVR in these patients, with mechanical (61%)
Large aortic annulus
Anatomic factors such as aortic annulus size significantly affect TAVR device success and long-term hemodynamic performance. Appropriate valve sizing using multidetector computed tomography (CT) is critical to lessen the incidence of PVL and life-threatening complications such as annulus rupture and valve embolization, especially in patients with large aortic annuli, defined as area ≥575 mm2 or perimeter ≥85.0 mm measured in systole (Figure 4), and extra-large aortic annuli (aortic annulus area
Vascular access
Transfemoral access is the preferred route for TAVR in most cases.48 Despite improvement in device technology and smaller delivery sheath profiles, vascular complications remain relevant, with reported incidences of 10% to 20%.49 The key risk factors include older age, female gender, obesity, peripheral vascular disease, calcification, and significant tortuosity of iliofemoral vessels.50 Because vascular complications are an independent predictor of morbidity and mortality, careful procedural
Young Patients
One of the key limitations of bioprostheses (surgical or transcatheter) is their long-term durability, particularly in younger patients, who have longer life expectancy and are therefore more likely to need repeat valve interventions. Because the initial TAVR studies included mostly octogenarians who were inoperable and at high risk, serial follow-up for identification of late valve dysfunction was not possible because subjects died from other causes long before their valves degenerated.6 The
Atrial fibrillation
The presence of valvular disease is considered an independent risk factor for AF.75 The prevalence of AF increases with age similarly to that of AS and is found in >9.0% of subjects aged >80 years.76 AF is observed in up to one-third of patients who undergo TAVR and has been associated with worse outcomes, with increased risk of all-cause and cardiovascular mortality.77 Most patients with nonvalvular AF end up on non–VKA oral anticoagulants these days because of the improved lifestyle and
Aortic Regurgitation
The most common causes of chronic severe AR are BAV and diseases of the ascending aorta and sinuses of Valsalva. Pure AR is also far less prevalent than AS (10% vs 34%).102 Previous studies with “off-label” use of TAVR to treat pure native AR with older-generation THVs found higher rates of embolization and migration and significant risk of PVL.103 Only a few reports have successfully shown that THV implantation using a less invasive approach is feasible104; however, this demands careful
Conduction Abnormalities
One of the key apprehensions after TAVR is an increased risk of conduction abnormalities because of increased forces on the atrioventricular valve and His’ bundle, leading to worsening of preexisting conduction disease or complete heart block and necessitating permanent pacemaker implantation (Figure 8). The overall clinical impact of pacemaker implantation is controversial; however, studies have shown its association with lengthier hospital stay107 and increased risk of all-cause death and
Future Directions
The expansion of TAVR to patients at low and intermediate risk will eventually provide an answer to the paramount question of long-term prosthesis durability. Future research should focus on comparing TAVR with surgery to address remaining unanswered questions such as which intervention is better for patients in the middle age range (51 to 69 years), for patients with moderate AS or asymptomatic severe AS, and for patients with multivalvular disease. Another key area to explore for TAVR is
Conclusions
Undoubtedly, there has been a paradigm shift in the treatment of AS from SAVR to TAVR over the last decade, which will certainly continue in 2023 and beyond. Refinement of procedural technique and THV technology, along with the accumulation of new data, will expand TAVR indications even further. Nonetheless, there remain many anatomic and clinical scenarios in which SAVR is a better strategy. In 2023, a heart team approach, shared decision-making, patient preference, the weighing of procedural
Disclosures
Dr. Reardon is a consultant for Medtronic, Boston Scientific, Abbott Medical, and Gore Medical.
Steven J. Yakubov is a consultant for Medtronic, Boston Scientific, and Foldax.
Dr. Rogers reports being a proctor and consultant for Boston Scientific, Edwards Lifesciences, and Medtronic; serving on the Advisory Board of Medtronic; and holding equity interest in Transmural Systems Inc.
Dr. Waksman reports serving on the advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and
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Funding: none.